Pelvic floor treatments and related tools and implants

ABSTRACT

Described are implants, tools, and methods useful for treating pelvic conditions such as prolapse, by placing an implant to support pelvic tissue, the implants, tools, and methods involving one or more of an insertion tool that works in coordination with a sheath, adjusting engagements, specific implants and pieces of implants, placement of implants at locations within the pelvic region, and insertion, adjusting, and grommet management tools.

PRIORITY CLAIM

This application claims benefit from International Application No.PCT/US2008/010926, which was filed on Sep. 19, 2008, which in turnclaims priority to U.S. Provisional Patent Application having Ser. No.60/974,314, filed on Sep. 21, 2007, titled FIXATION DELIVERY DEVICE ANDMETHOD; and U.S. Provisional Patent Application having Ser. No.61/012,260, filed on Dec. 7, 2007, titled PELVIC FLOOR TREATMENTS ANDASSOCIATED IMPLANTS, wherein the entireties of said patent applicationsare incorporated herein by reference.

FIELD OF THE INVENTION

The invention relates to apparatus and methods for implanting a surgicalimplant, e.g., a pelvic implant for treating pelvic conditions. Themethods include an implant to support tissue. Examples of conditionsinclude conditions of the female or male anatomy, and specificallyinclude treatments of pelvic conditions such as female or male urinaryand fecal incontinence, and treatment of female vaginal prolapseconditions including enterocele, rectocele, cystocele, vault prolapse,conditions of the pelvic floor, and any of these conditions incombination.

BACKGROUND

Biological implants for supporting tissue, to treat medical conditions,are generally known and used to treat various ailments. Variousconditions of female and male pelvic anatomy can be treated bysupportive implants. For example, pelvic prolapse conditions, includingvaginal prolapse, can be caused by the weakening or breakdown of variousparts of the pelvic support system such as the pelvic floor or tissuesurrounding the vagina. Similarly, weakened tissues can result in fecalincontinence, urinary incontinence, and levator avulsion and otherconditions of the pelvic floor. Broadly, due to the lack of support,structures such as the uterus, rectum, bladder, urethra, smallintestine, levator and muscle of the pelvic floor, and vagina, may beginto fall out of their normal positions. Pelvic conditions such as these,as well as other conditions of biologic tissue, can be treated byplacement of synthetic or biological implants to support weakened oraffected tissues.

SUMMARY

The invention involves implants, systems, kits, and method, for placinga surgical implant for supporting tissue. Embodiments of the inventioninvolve the use of a tool (sometimes referred to as an “insertion tool”or “introducer tool”) that includes a shaft and a sheath that engagesthe shaft in a “covered” and an “uncovered” configuration, relative tothe distal shaft end. In one exemplary embodiment a sheath includes ahollow member such as a tube made of hard or flexible plastic, having ashape that can at least partially surround a portion of or a totallength of a shaft of an introducer tool. In a covered configuration, thesheath covers and can protect the distal end of the shaft, as well as atissue fastener that can be engaged with the distal shaft end; in anuncovered configuration the sheath, still engaged with the shaft, doesnot cover the distal end or an engaged tissue fastener but allows thetissue fastener to contact and become fixed to tissue. In this exampleembodiment, the sheath (e.g., tube or tubing) can exhibit a profile thatallows the introduction and placement of a fixation element (e.g.,tissue fastener, or tissue engager such as a self-fixating tip, etc.)into the limited space available during a surgical procedure. The tubingprevents the fixation element and device from catching on pelvic tissue.Additionally, the tubing protects the physician's glove from catchingand tearing. The tubing also helps to keep the fixation element in placeon the insertion tool.

Both ends of a sheath (e.g., tubing) can be open. The first end can beopen to allow entry of the shaft (distal end) of the insertion tool(e.g., fixation device).

Optionally a sheath in the form of a tube or tubing can includes adepth-limiting feature, which refers to a feature that can limit thedepth into which a tissue fastener such as a self-fixating tip canpenetrate tissue. Upon the act of fixation, attaching a tissue fastenerto tissue, the depth-limiting feature can act to prevent inadvertentover-insertion of the fixation element in the fixation site. The secondend of the tube is open to allow exposure of the distal end of the toolshaft (e.g., tip) for placement of at tissue fastener. A distal end of ashaft (e.g., tip) may be of a configuration to engage a tissue fastener,e.g., rounded, slotted, domed, blunted, or the like to prevent injury orpuncturing of nearby organs.

The insertion tools allow fixation of a tissue fastener when the distalend of a tool shaft (e.g., needle tip), which is engaged with a tissuefastener, is exposed from the sheath (e.g., tubing). This exposure ispossible by interaction between the tubing and needle. The interactionmay be mechanical (e.g., involving a mechanism built into the handle,shaft, or sheath) or manual (e.g., movement of the sheath by the user).Either of the shaft or sheath may be static while the other moves or, inan alternative embodiment, both components may move. A pin, button,spring, or trigger may be used to initiate the exposure of the needletip and fixation element.

The present disclosure identifies pelvic implants, components ofimplants, related devices, systems and kits containing these, andmethods of using these for treating pelvic conditions such asincontinence (various forms such as fecal incontinence, stress urinaryincontinence, urge incontinence, mixed incontinence, etc.), vaginalprolapse (including various forms such as enterocele, cystocele,rectocele, apical or vault prolapse, uterine descent, etc.), conditionsof the pelvic floor and result from weakness or trauma of pelvic floormuscles such as the levator (“levator ani”) or coccygeus muscle(collectively the pelvic floor), and other conditions caused by muscleand ligament weakness. Exemplary methods can involve treatment ofvaginal prolapse, including anterior prolapse, posterior prolapse, orvault prolapse. A method can be transvaginal, involving a singleincision in the vaginal tissue, with no external incision.

Any implants or methods described can involve a tissue fastener that isdesigned to secure an extension portion of an implant to tissue. Thesemay be in the form of a soft tissue anchor, a self-fixating tip,fixation element, etc., which can be inserted into soft tissue orconnected to soft tissue, and remain in or contacted with the tissue tosupport the implant.

An implant can be one that is useful in supporting tissue, e.g., pelvictissue such as the urethra, rectum, pelvic muscle (e.g., levator ani),rectum, etc. An implant can include features including a support portionfor supporting tissue, an extension portion to connect tissue internallyto tissue, and optional features such as: an adjusting engagement(one-way or two-way); combinations of a one-way and a two-way adjustingengagement present on a single implant segment (e.g., extension portionpiece or segment or scaffold portion piece or segment); scaffoldportions as described; multiple pieces (see PCT/US08/009,066, filed Jul.25, 2008, titled PELVIC FLOOR TREATMENTS AND RELATED TOOLS AND IMPLANTS,the entirety of which is incorporated herein by reference). Exemplaryembodiments of implants and methods can involve the use of an extensionportion piece that includes a mesh portion and a non-mesh portion.Optionally, an implant and method of implanting an implant may furtherinvolve a grommet management tool, an adjusting tool, or both.

One embodiment of the invention includes a system that repairs prolapsewithout external needle passes. The system includes an implant that canbe implanted through a single, transvaginal incision. The implant cantreat posterior or anterior prolapse by affixing elements of the implantat the sacrospinous ligament, coccygeus muscle, or both. The implant canbe placed, secured, and adjusted transvaginally via a single vaginalincision. Unlike certain current systems for use in treating posteriorprolapse, this system can be implanted in the body without externaltrans-gluteal needle passes and is, thus, less invasive. The systemgenerally comprises fixation arms, a center graft, a delivery device,and/or a locking system.

In addition to prolapse, the invention may be used in pelvic treatmentssuch as fecal incontinence, male and female urinary incontinence, andpost-prostatectomy repairs. Moreover, the invention may be used in othersurgical treatments where tissue anchoring is involved, such as grafts,hernia repair, and shoulder repair.

In one aspect the invention relates to a surgical insertion tool usefulfor implanting a pelvic implant. The tool includes a handle; a shafthaving a proximal shaft end attached to the handle, and a distal shaftend; and a sheath that engages the shaft and allows at least twoconfigurations: a covered configuration in which the sheath covers thedistal shaft end, and an uncovered configuration in which the sheathcovers a portion of the shaft and does not cover the distal shaft end.

In another aspect the invention relates to a tool comprising a sheath,as described, in combination with an extension portion of an implant.The extension portion includes a tissue fastener at a distal end, andthe tissue fastener is capable of engaging a distal end of the shaft.

In another aspect the invention relates to method of implanting animplant in a patient. The method includes: providing a combination oftool that works with a sheath, as described, and an implant, the implantincluding an extension portion having a tissue fastener at a distalshaft end; engaging the tissue fastener with the distal shaft end,placing the sheath over the shaft and engaged tissue fastener with thesheath in a covered configuration that covers the distal shaft end andengaged tissue fastener, inserting the shaft and engaged tissue fastenerinto a patient, with the sheath placed over the shaft in the coveredconfiguration, moving the sheath to an uncovered configuration thatuncovers the tissue fastener, and fastening the tissue fastener totissue.

The following patent documents are incorporated herein by reference intheir entireties: US Patent Publication No. US 2005/0250977 A1; USPatent Publication No. US 2005/0245787 A1; US Patent Publication No. US2002/0161382 A1; US Patent Publication No. US 2006/0260618 A1; U.S. Pat.No. 6,652,450; U.S. Pat. No. 6,612,977; U.S. Pat. No. 6,802,807; U.S.Pat. No. 7,048,682; U.S. Pat. No. 6,641,525; U.S. Pat. No. 6,911,003;U.S. Pat. No. 7,070,556; U.S. Pat. No. 6,354,991; U.S. Pat. No.6,896,651; U.S. Pat. No. 6,652,449; U.S. Pat. No. 6,862,480; U.S. Pat.No. 6,712,772; U.S. Pat. No. 6,981,983; U.S. Pat. No. 7,131,944; U.S.Pat. No. 7,131,943; U.S. Pat. No. 7,267,645; U.S. Pat. No. 6,971,986;U.S. Pat. No. 6,626,916; U.S. Pat. No. 7,407,480; U.S. Pat. No.7,351,197; and WO 2007/149348 A2, filed Jun. 15, 2007, titled “SurgicalImplants, Tools and Methods for Treating Pelvic Conditions.”

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B illustrate a side, cut-away view of an example of aninsertion tool as described.

FIG. 1C illustrates a side view of an example of an insertion tool asdescribed.

FIG. 1D illustrates a side view of an example of an insertion tool asdescribed.

FIG. 1E illustrates a closer side view of a distal end of the insertiontool of FIG. 1D.

FIG. 1F illustrates an end view of a distal end of the insertion tool ofFIG. 1D.

FIGS. 2A and 2B illustrate side cut-away views of an example of a handleof an insertion tool, including a stop mechanism.

FIGS. 3A and 3B illustrate a side view and a top view, respectively, ofan example of a sheath as described.

FIG. 4 illustrates an exemplary implant piece as described.

FIGS. 5A and 5B illustrate exemplary extension portion pieces, asdescribed.

FIGS. 6A and 6B illustrate exemplary grommet-management tools, asdescribed.

FIGS. 7A, 7B, 8A, and 8B illustrate exemplary adjusting tools, asdescribed.

FIG. 9 illustrates an exemplary kit, as described.

FIGS. 10A and 10B illustrate side, cut-away views of an example of aninsertion tool as described.

All drawings are schematic and not to scale.

DESCRIPTION

This description is meant to be illustrative only and not limiting.Other embodiments of this invention will be apparent to those ofordinary skill in the art in view of this description.

The invention involves surgical tools, instruments, assemblies,implantable articles for supporting tissue, and kits and systems thatinclude combinations of these. Examples include tools, instruments,assemblies, and articles for treating pelvic floor disorders such asfecal or urinary incontinence, including stress urinary incontinence(SUI), vaginal prolapse (e.g., anterior or posterior), conditions of thepelvic floor relating to, e.g., muscle of the levator, etc. According tovarious embodiments a surgical implant can be used to treat a pelviccondition by surgically placing a pelvic implant to treat a conditionsuch as prolapse (e.g., vaginal or otherwise), incontinence (male orfemale), etc. As more specific examples, an implant can be implanted ina male or a female patient to treat a condition such as urgeincontinence; stress urinary incontinence; mixed incontinence; overflowincontinence; functional incontinence; fecal incontinence; prolapse(e.g. vaginal or uterine); enterocele (e.g. of the uterus); rectocele;cystocele; anatomic hypermobility; conditions of the pelvic floor causedby weakness or trauma of pelvic floor muscles such as the levator(“levator ani”) or coccygeus muscle (collectively the pelvic floor);other conditions caused by muscle and ligament weakness; andcombinations of these.

In general, methods and devices described herein involve an insertiontool that includes a handle, a shaft, and a sheath that can cover atleast a portion of the sheath. An exemplary insertion tool can include ahandle and a shaft that includes a proximal shaft end attached to thehandle, and a distal shaft end. A sheath is a separate piece that canengage the shaft in at least two configurations: a covered configurationand an uncovered configuration. In the covered configuration, a sheathcovers the distal shaft end, e.g., in a manner that protects and shieldsthe distal shaft end and an optional tissue fastener that may be engagedwith the distal shaft end. In the uncovered configuration the sheathdoes not cover the distal shaft end and allows the distal shaft end anda tissue fastener that may be engaged with the distal shaft end toengage tissue. In the uncovered configuration the sheath can also cover(completely or partially) the proximal shaft end and a length of shaftbetween the proximal shaft end and the distal shaft end.

One example of an insertion tool according to the present description isshown (in a cut-away side-view) at FIGS. 1A and 1B. Tool 10 includeshandle 2, shaft 4, and sheath 6. Shaft 4 is a solid needle shaft thatincludes proximal shaft end 8 attached to distal handle end 12, anddistal shaft end 14, designed to engage a tissue fasteners. Recess 16 isa space located at distal end 12 of handle 2, extending longitudinallyinto handle 2. Generally, the recess is an open space between shaft 4and a portion of distal handle end 12, that can receive a proximal endof shaft 6 or a portion thereof. As illustrated, recess 16 is theannular space between the outer cylindrical surface of shaft 4 and theinner cylindrical surface 16 a of distal end 12 of handle 2. Recess 16is sized to allow a proximal end (e.g., illustrated as a hollowcylinder) of sheath 6 to fit and become located within recess 16, atdifferent depths, for both covered and uncovered configurations.

The size of a recess (e.g., recess 16) can include a length (along thelongitudinal distance of the handle, designated “L”) and a width ordiameter (along the width of the handle). Another relevant length islength d, which is the distance from a stopping mechanism (pin 22) tothe end of recess 16, which is surface 15; this distance, d (see FIG.1A), is the same as the length of shaft distal end that is uncovered inan “uncovered” configuration (see FIG. 1B). This distance also relatesto a maximum depth that the shaft distal end can penetrate into tissue,because the distal end of the sheath will prevent further penetration.

A diameter of a recess, e.g., recess 15, can be sufficient to allowentry of a proximal end of a sheath, and can be slightly larger than thediameter of the sheath. A useful diameter may be, e.g., from 0.5 to 1.0centimeter. A length (L) of a recess in a handle into which a sheath canenter may be sufficient to allow the sheath to change from a covered toan uncovered configuration by entry or by further entry into the handle,i.e., movement of the sheath along the shaft in the direction toward thehandle. The length can be, e.g., from 1.5 to 3.5 centimeters, such asfrom 2.0 to 3.0 centimeters.

Still referring to FIGS. 1A and 1B, lever 20 is biased by spring 24 toplace pin 22 at a location within recess 16 to contact a surface at aproximal end of sheath 6, to thereby limit movement of sheath 6 intorecess 16, toward handle 2. FIG. 1A shows sheath 6 in a coveredconfiguration. In this covered configuration, a distal end of sheath 6extends to cover and enclose distal shaft end 14. FIG. 1B shows sheath 6in an uncovered configuration. In this uncovered configuration thedistal end of sheath 6 does not enclose distal shaft end 14 but leavesdistal shaft end 14 uncovered. The uncovered configuration is achieved,starting from the covered configuration, by moving sheath 6 in aproximal direction (shown by arrow A) to slide sheath 6 toward handle 2,and allowing the proximal end of sheath 6 to become located deeperwithin recess 16.

With regard to one embodiment of an insertion tool, FIGS. 2A and 2Binclude details of structure of a distal handle end including a recess,a proximal shaft end, a sheath, and a mechanical stop that engages thesheath. As shown in a cut-away side view, tool 40 includes handle 42,shaft 44, and sheath 46 (e.g., in the form of a plastic tube). Shaft 44is a solid needle shaft that includes proximal shaft end 48 attached todistal handle end 52. Recess 56 is a space located at distal end 52 ofhandle 42, extending longitudinally into handle 42 and sized to allow aproximal end of sheath 46 to fit and become located within recess 56.Lever 60 is biased by spring 64 to place pins (proximal pin 62 anddistal pin 63) (e.g., “extensions”) at a location within recess 56 andin engagement with sheath 46 to limit movement of sheath 46 into or outof recess 56. A distal surface 61 of proximal pin 62 contacts a proximalend surface 54 of sheath 46, while distal pin 63 engages aperture 59located at the proximal end of sheath 46. Proximal pin 62 extendsthrough aperture 53 of distal end 52 of handle 42, and distal pin 62extends through aperture 55 of distal end 52 of handle 42.

FIG. 2A shows sheath 46 in a covered configuration. In this coveredconfiguration, a distal end of sheath 46 (not shown) extends to cover adistal shaft end (not shown) of shaft 44. Also in this coveredconfiguration, sheath 46 extends only partway into recess 56; pins 62and 63 engage surface 54 and aperture 59 of the proximal end of shaft 46to prevent movement of sheath 46 in a distal or a proximal directionrelative to shaft 44. FIG. 2B shows sheath 46 in an uncoveredconfiguration in which the distal end (not shown) of sheath 46 does notenclose the distal shaft end of shaft 44 (not shown) but leaves thedistal shaft end uncovered. The uncovered configuration is achieved,starting from the covered configuration, by moving sheath 46 in aproximal direction (shown by arrow A), to slide sheath 46 toward handle42 and allow the proximal end of sheath 46 to become located deeperwithin recess 56 as illustrated at FIG. 2B.

The insertion tool of FIGS. 1A, 1B, 2A, and 2B, involve a stoppingmechanism located on a handle that associates with the sheath. Inalternate embodiments a stopping mechanism may be located somewhereother than the handle, e.g., along the shaft an insertion tool, or asanother alternative a tool may not include or require a stoppingmechanism. An example of an insertion tool that does not require astopping mechanism at a handle is shown at FIG. 1C. Insertion tool 80includes handle 82, shaft 84, and sheath 86 having proximal end 87 anddistal end 89. Shaft 84 is a solid needle shaft that includes proximalshaft end 81 attached to distal handle end 83, and distal shaft end 91,shown in engagement with tissue fastener 90, which is located at adistal end of mesh extension portion 88. (Extension portion 88 may beintegrally or otherwise connected to an implant, e.g., a support portionof an implant, or may be a separate piece of an implant.) Thumb surface85 is located at proximal end 87 of sheath 86 and allows a user tomanipulate sheath 86 using a thumb, while holding handle 82, e.g., movesheath 86 from a covered to an uncovered configuration. An optionalstopping mechanism (not shown) may be located at the shaft, if desired.The stopping mechanism may include a surface located on shaft 84, suchas an extension, that engages a surface on sheath 86; when engagement ofthe surfaces prevents movement of sheath 86 relative to shaft 84, anddisengagement of the surfaces allows movement of sheath 86 relative toshaft 84.

Another alternate embodiment of an insertion tool is one having astopping mechanism located on a handle, but that does not include a“recess” in the handle that completely surrounds the shaft at thelocation of the shaft connecting to the handle, e.g., as shown at FIGS.1A and 1B. Referring to FIG. 1D, insertion tool 92 includes handle 97,shaft 96, and sheath 95 having proximal end 93 and distal end 105. Shaft96 is a solid needle shaft that includes a proximal shaft end attachedto a distal handle end, and a distal shaft end, shown in engagement withtissue fastener 107, which is located at a distal end of mesh extensionportion 111. (Extension portion 111 may be integrally or otherwiseconnected to an implant, e.g., a support portion of an implant, or maybe a separate piece of an implant.) A component of a mechanical stop isstop 98, extending distally from handle 97, which can engage a surfaceat the proximal end of sheath 95. For example to remove the stop,proximal end 93 of sheath 95 can be deflected toward shaft 95 to avoidcontact with stop 98 (e.g., by pressure using a user's thumb); theproximal end of sheath 95 can then move into space 99 between shaft 95and stop 98 to allow sheath 95 to move in direction A and convert sheath95 from a covered configuration (as illustrated) to an uncoveredconfiguration. Another optional mechanical stop, surface (e.g., bump)101 located at shaft 95, cooperates with a surface (e.g., depression)103 in sheath 95. This stop too can be removed by deflecting proximalsheath end 93 in a direction that disengages surface 101 from depression103, allowing sheath 95 to move in direction A.

A sheath can be made of a rigid, semi-rigid, or non-rigid material thatis flexible or inflexible. Examples of general types of materials arethose often used with surgical tools, such as metals, ceramics, andplastics or other polymeric materials. For an insertion tool thatincludes a curved shaft, a sheath can be sufficiently flexible andoptionally elastic to allow the sheath to be placed along a desiredlength of the shaft, including the curve.

Certain preferred materials can be polymeric materials that can beformed into a sheath (e.g., a cylindrical tube having two open ends) toproduce a flexible yet self-supporting sheath. A preferred sheath can beflexible in that the sheath can bend to a degree, such as to allowplacement onto a curved shaft, and then remain bent if necessary toconform to a curvature of a tool shaft. A preferred sheath can beself-supporting, meaning that if one end of the sheath is supported, thesheath does not substantially fold or bend under the force of thesheath's its own weight.

Polymeric materials that can be useful to produce a sheath, optionallybut not necessarily a flexible yet self-supporting sheath, can bepolymers that include polyolefins such as polyethylene (e.g., lowdensity polyethylene), polypropylene, polyacrylates, polymethacrylates,polyesters, urethanes, silicones, and the like.

A sheath can exhibit shape and dimension to allow the sheath to cover ashaft of an insertion tool. Certain embodiments of sheaths can include acontinuous tube of a length that is approximately the length of theshaft between a distal shaft end and a proximal shaft end at anattachment to a handle, not including a length of the shaft that iscontained in a recess of the handle. Exemplary lengths of a sheath willdepend on the use of the insertion tool. For an insertion tool intendedto be used to place a tissue fastener at a posterior location of apelvic region, through a vaginal incision, a length of a sheath can be,e.g., from about 15 to 28 centimeters, e.g., from about 18 to 24centimeters. For an insertion tool intended to be used to place a tissuefastener at an obturator foramen, through a vaginal incision, a lengthof a sheath can be, e.g., from about 8 to 15 centimeters, e.g., fromabout 9 to 13 centimeters. If the sheath includes a curve the lengthincludes the full length including the length of curved portion(arclength) in a straightened condition.

The diameter of a sheath such as a semi-rigid tube can be sufficient toallow the hollow interior of the tube to cover a combination of a shaftof an insertion tool and extension portion of an implant, e.g., an innerdiameter of a sheath may be from 0.5 to 1.2 centimeters, such as from0.5 to 0.8 centimeters. According to certain embodiments of sheaths, adiameter at a distal sheath end may gradually reduce, moving distally(see FIG. 1E).

The thickness of a sidewall of a sheath can be consistent along thelength of the sheath, and in certain preferred embodiments can besufficient to result in a sheath that is self-supporting. A sidewallthickness that will be useful to achieve these functions can depend onthe sidewall material. A useful sidewall thickness for a sheath made ofa polymeric material such as a polyolefin may be in the range from 0.3to 1.5 millimeter.

A proximal end of a sheath can optionally include an aperture in asidewall that can be used to engage a mechanical stop such as a pin oran extension, to inhibit movement of the sheath along the length of theinsertion tool shaft.

FIG. 3A shows a side view of sheath 70 having proximal end 72, distalend 74, sidewall 76, and aperture 78. As illustrated, sheath 70 is acontinuous self-supporting tube made, e.g., of a polymeric material suchas polyethylene. The tube is constructed of a solid polymer havingopenings (end apertures) at each of the proximal and distal ends, andsidewall aperture 78 within the sidewall at proximal end 72. The lengthof sheath 70 measured from the opposing ends and including the length ofthe arc of the curve is sufficient to cover a needle of a tool that canreach a posterior pelvic location through a vaginal incision, e.g., from20 to 22 centimeters. For reaching a different location, e.g., anobturator, through a vaginal incision, the length can be different,e.g., shorter. The inside diameter of the sheath is sufficient toenclose a solid needle shaft and a mesh material of an elongateextension portion, e.g., from 0.5 to 1.0 centimeters. Sidewall aperture78 is dimensioned to accept a pin, extension, or other mechanical stopuseful to limit movement of the sheath relative to an insertion toolshaft, when the pin, extension, or mechanical stop engages sidewallaperture 78.

A sheath can include a distal end that covers a tissue fastener, andalso optionally exhibits a reduced profile for easing insertion of thesheath distal end through tissue. For example a sheath distal end can betapered to reduce a cross-sectional dimension such as diameter. FIGS.1D, 1E, and 1F illustrate a tapered sheath distal end. Referring toFIGS. 1E (side cross section) and 1F (end view), sheath distal end 105includes a tapered profile embodied as a diameter that decreases alongthe length of the sheath distal end, moving distally. The tapered distalend can preferably include an opening that allows a tissue fastener topass through the reduced-diameter distal end, such as by allowingpassage of lateral extensions of a self-fixating tip. FIG. 1F showslateral slots 117 that allow lateral extensions 118 to pass throughdistal end 115.

In use, a tool as described (e.g., tool 10, tool 40, tool 80, tool 92,or as otherwise described) can be used to place an implant in a patient.General steps of using a tool as described can include engaging a tissuefastener of an implant with a distal shaft end (e.g., 14) and placing asheath (e.g., 6, 46) over the shaft and engaged tissue fastener.Generally, in the covered configuration, extension portion of theimplant (e.g., an extension portion piece), or a segment thereof, andthe shaft of the insertion tool, will be covered at least in part by thesheath, i.e., will be located within the sheath. See, e.g., FIGS. 1C and1D. The assembly of the tool with sheath and engaged tissue fastener canbe inserted into a patient in the covered configuration with the distalsheath end covering the distal shaft end and engaged tissue fastener.Once inside, the position of the sheath can be changed from the coveredto an uncovered configuration to expose the tissue fastener at thedistal shaft end. In an uncovered configuration, as an example, a lengthof from 0.3 to 1.5 centimeters of the distal end of the shaft can beuncovered, such as from 0.8 to 1.5 centimeters (this measurement can bedone either with an engaged tissue fastener, in which the length of thetissue fastener is included, or without an engaged tissue fastener).This change in configurations can optionally be performed in conjunctionwith a movement of a mechanical stop, e.g., at the handle, along theshaft, or at any selected location of the tool. The exposed tissuefastener can be fastened to (e.g., fixated to, inserted into, orotherwise engaged to) tissue, and the tool including the sheath can beremoved.

Exemplary implants that can be used for placement by an insertion toolas described can be useful for supporting any tissue of a living body,including but not limited to pelvic tissue. When used to support pelvictissue an implant can include a tissue support portion that can be usedto support pelvic tissue such as a urethra (which includes the bladderneck), bladder, rectum, vaginal tissue (Level 1, Level 2, Level 3, orcombinations of these), pelvic floor tissue (e.g., levator muscletissue), etc. During use, the tissue support portion is typically placedin contact with and attached to tissue to be supported, such as byattachment using one or more sutures. An implant can additionallyinclude one or more extension portion attached or attachable to thetissue support portion. An extension portion may be a portion referredto as a “scaffold” portion, which can be attached to a tissue supportportion or another extension portion. A tissue fastener, dilator, orconnector, etc., can be included at an end of an extension portion.

The tissue support portion can be designed to support a specific type ofpelvic tissue such as the urethra, bladder (including the bladder neck),vaginal tissue (anterior, posterior, apical, etc.), rectum, tissue ofthe pelvic floor such as levator muscle, etc. The tissue support portioncan be sized and shaped to contact the desired tissue when installed,e.g., as a “sling” or “hammock,” to contact and support pelvic tissue.

Extension portions are pieces of material, generally elongate orotherwise extended from a tissue support portion, or in the case of ascaffold portion from another extension portion. Embodiments ofextension portions can be useful to either pass through or attach totissue of the pelvic region to thereby provide support for the tissuesupport portion and the supported tissue. One or multiple (e.g., one,two, four, or six) extension portions can extend from a tissue supportportion for attachment to tissue in the pelvic region, such as byextending to an internal anchoring point (or “fixation point”) (forattachment by bone anchor, tissue fastener, etc. as described), orthrough a tissue path to an external incision.

An implant can optionally include a scaffold portion (which can beconsidered a type of extension portion) that can be extended internallywithin a patient and secured to tissue of a pelvic region or to alocation of the implant. A scaffold portion can be used to support atissue support portion or another extension portion attached to thescaffold portion, e.g., along a length of the scaffold portion andbetween two ends of the scaffold portion. A scaffold portion can havetwo ends. Either end can be attached internally to tissue of the pelvicregion, or to the implant, such as to a tissue support portion, anotherextension portion, or another scaffold portion. An end of a scaffoldportion can be securely (non-adjustably) attached to a tissue supportportion or another extension portion, such as by a suture, rivet,staple, etc.; may be integrally formed with the tissue support portionor extension portion; or may be adjustably attached to a tissue supportportion or an extension portion using an adjusting engagement. Ascaffold portion may also optionally include an adjusting engagementalong the length of the scaffold portion.

A “multi-piece” implant refers to an implant that includes one or more“support portion piece,” and one or multiple “extension portion piece”(which may be a “scaffold portion piece”) as separate pieces of theimplant. An extension portion piece or scaffold portion piece can beseparate from a support portion piece, and can be connected through oneor multiple adjusting engagements. The support portion piece includes atissue support portion.

Exemplary implants can be made of materials and may be generally shapedand sized with certain individual features that may be found in previousimplants, but can be modified to include features as described hereinsuch as a scaffold portion, an adjusting engagement, any of the varioustissue fasteners described herein, multi-piece construction, etc., andcan be adapted for use according to methods described herein, e.g.,involving tools that incorporate a sheath. An implant can have featuresdescribed in the following exemplary documents: U.S. patent applicationSer. No. 10/834,943, filed Apr. 30, 2004; U.S. patent application Ser.No. 10/306,179, filed Nov. 27, 2002; U.S. patent application Ser. No.11/347,063, filed Feb. 3, 2006; U.S. patent application Ser. No.11/347,596, filed Feb. 3, 2006; U.S. patent application Ser. No.11/347,553, filed Feb. 3, 2006; U.S. patent application Ser. No.11/347,047, filed Feb. 3, 2006; U.S. patent application Ser. No.11/346,750, filed Feb. 3, 2006; U.S. patent application Ser. No.11/398,368, filed Apr. 5, 2005; U.S. patent application Ser. No.11/243,802, filed Oct. 5, 2005; U.S. patent application Ser. No.10/840,646, filed May 7, 2004; and International patent applicationnumber PCT/US2006/028828, having an International Filing Date of Jul.25, 2006; International Application No. PCT/US2007/004015 entitled“SURGICAL ARTICLES AND METHODS FOR TREATING PELVIC CONDITIONS,” filedFeb. 16, 2007; International Publication No. WO 2008/013867 entitled“SURGICAL ARTICLES AND METHODS FOR TREATING PELVIC CONDITIONS,”published Jan. 31, 2008; International Application No. PCT/US2008/08006entitled “SURGICAL ARTICLES AND METHODS FOR TREATING PELVIC CONDITIONS,”filed Jun. 27, 2008; International Application No. PCT/US2008/09066entitled “PELVIC FLOOR TREATMENTS AND RELATED TOOLS AND IMPLANTS,” filedJul. 25, 2008; and International Application No. PCT/US2008/000033entitled “METHODS FOR INSTALLING SLING TO TREAT FECAL INCONTINENCE, ANDRELATED DEVICES,” filed Jan. 3, 2008; the entireties of each of thesedisclosures being incorporated herein by reference in their entireties.

Examples of commercial implants include those sold by American MedicalSystems, Inc., of Minnetonka Minn., under the trade names Apogee®,Perigee®, and Elevate™ for use in treating pelvic prolapse (includingvaginal vault prolapse, cystocele, enterocele, etc.), and Sparc®,Bioarc®, Monarc®, and MiniArc™ for treating urinary incontinence.Implants useful according to the present description can include one ormore features of these commercial implants.

An implant may include portions, pieces, or segments, that are syntheticof biological material (e.g., porcine, cadaveric, etc.). Extensionportions and scaffold portions (made of a single piece or of more thanone piece) may be, e.g., a synthetic mesh such as a polypropylene mesh.A tissue support portion may be synthetic (e.g., a polypropylene mesh)or biologic. (As used herein, the term “portion of implant” (or “implantportion”) refers generally to any piece, segment, or portion (e.g.,extension portion or scaffold portion) of an implant. The term “segmentof implant” (or “implant segment”) refers to an elongate length ofimplant material, such as a length of an elongate section of anextension portion or a scaffold portion.)

Examples of implants for treating vaginal prolapse (e.g., anteriorvaginal prolapse, posterior vaginal prolapse, vaginal vault prolapse)can include a central support portion and from two to four to sixextension portions, and may take the form of an integral piece of meshor other implant material, or multiple pieces of mesh or other implantmaterial attached in a modular fashion. See, e.g., Assignee's copendingU.S. patent application Ser. Nos. 11/398,369; 10/834,943; 11/243,802;10/840,646; PCT/2006/028828; among others. Particularly useful examplesof implants for treating vaginal prolapse, using any one or acombination of devices or methods as described herein can be implantsdescribed in Assignee's copending International Patent Application No.PCT/US2007/014120, entitled “SURGICAL IMPLANTS, TOOLS, AND METHODS FORTREATING PELVIC CONDITIONS,” filed Jun. 15, 2007, and InternationalApplication No. PCT/US2008/09066 entitled “PELVIC FLOOR TREATMENTS ANDRELATED TOOLS AND IMPLANTS,” filed Jul. 25, 2008, the entirety of whichis incorporated herein by reference.

According to various embodiments of implants described herein, animplant can include pieces or portions that are adjustably connectedtogether by an adjusting engagement, which may be either a one-wayadjusting engagement or a two-way adjusting engagement, to allow aportion or a segment of an implant to be moved relative to anotherportion or segment, and adjusted as to length, tension, or positioning.As an example, an extension portion piece can be attached to a supportportion piece at an adjusting engagement to allow adjustment of a lengthof extension portion. Alternately or in addition, a scaffold portion orscaffold portion piece can be attached to a support portion piece or toan extension portion at an adjusting engagement to allow adjustment oflength or tension of a scaffold portion.

Some adjusting engagements can allow free two-way movement of one piecerelative to another piece (e.g., a “two-way” adjusting engagement). Thistype of adjusting engagement allows easy movement of a segment ofimplant in two directions through an adjusting engagement. The forceneeded to move the segment of implant in one direction is substantiallyequal to the force needed to move the segment in the opposite direction,and, preferably, the two-way adjusting engagement does not substantiallyhinder the movement of a segment of implant through the adjustingengagement with frictional surfaces such as extensions (e.g., “teeth”)extending into an aperture through which the segment of implant ismoved. As an example, a two-way adjusting engagement may include an open(smooth) aperture that may be circular, oval, elongate such as in theform of a slit or slot, etc. The aperture may optionally be reinforcedby a reinforcement of a shape that is similar to the aperture, such asby a fabric or a polymeric material such as a grommet (e.g., a “loosegrommet” or “eyelet”), which may be circular, or may be of anothershape. The reinforcement (e.g., grommet) defines a reinforced aperturethrough which a segment of implant can pass relatively freely and withthe same resistance two different directions.

Other adjusting engagements may allow for one-way adjustment such asshortening of a length of the extension portion or scaffold portion.These adjusting engagements can be referred to as “one-way” adjustingengagements, and allow adjustment of a length of an implant portion inone direction and not in an opposite direction. An exemplary one-wayadjusting engagement can include an aperture through which a segment ofimplant can extend, and one or multiple surfaces (e.g., extensions orteeth) that frictionally engage the segment of implant, e.g., byextending into or toward the aperture or otherwise contacting thesegment of implant to inhibit movement of the segment of implantrelative to the adjusting engagement. The one-way engagement canpreferentially allow movement of the segment of implant through theaperture in one direction while inhibiting movement of the segment ofimplant in an opposing direction.

Still other embodiments of adjusting engagements may allow for two-wayadjustment of a length of extension portion in one configuration (an“open” configuration), and further include a structure or mechanism thatcan be switched, activated, moved, removed, closed, or opened, to securea frictional adjusting engagement at a selected location to preventmovement in either direction.

In use of an adjusting engagement, a tissue fastener at one end of anextension portion piece can placed at tissue as desired (and “fixed” or“secured”) and a second (loose) end of the extension portion piece canbe passed through an adjusting engagement, e.g., a two-way adjustingengagement. The engagement is adjusted to place the support portionpiece at a desired position (length) of the extension portion piece. Asecond adjusting engagement, e.g., a one-way grommet, is slid onto theloose end of the extension portion piece and slid along the extensionportion piece to a location at the two-way adjusting engagement. Theone-way adjusting engagement moves easily along the extension portionpiece in the direction toward two-way adjusting engagement, and does notmove easily in the opposite direction. Once placed in position near thetwo-way adjusting engagement of the support portion piece, the supportportion piece is prevented from moving along the extension portion piecein the direction of the one-way adjusting engagement.

Implants as described can include a tissue fastener (also referred toherein as a “fixation element”) at a distal end of an extension portion,which is the end not attached to a tissue support portion or otherportion or segment of an implant. (The term “distal” as used herein maybe used to refer to an end of a structure that is “away from” adifferent structure, such as a distal end of an extension portion thatis the end away from a connection to a tissue support portion. The term“distal” may also (based on arbitrary selection) generally refer to alocation that is relatively more posterior to a patient, and relativelyfarther away from a surgeon performing a method as described; “proximal”generally refers to a location that is relatively more anterior to apatient, and relatively closer to a surgeon performing a method asdescribed. Any other convention, such as an opposite convention, couldalternately be used to refer to features of devices and methods asdescribed.)

A tissue fastener can be of various types, including, as examples, aself-fixating tip that is inserted into soft tissue and frictionallyretained; soft tissue anchors; biologic adhesive; a soft tissue clampthat can generally include opposing, optionally biased, jaws that closeto grab tissue; and opposing male and female connector elements thatengage to secure an end of an extension portion to tissue. (SeeInternational Patent Application No. PCT/US2007/014120, entitled“Surgical Implants, Tools, and Methods for Treating Pelvic Conditions”,filed Jun. 15, 2007, the entirety of which is incorporated herein byreference.) An implant may also have extension portions that do notinclude a tissue fastener at a distal end, for example if the distal endis designed to be secured to tissue by other methods (e.g., suturing),or is intended to pass through an external incision, in which case theextension portion may include a connector, dilator, or dilatingconnector, which connects to an elongate tool that can be used to eitherpush or pull the connector, dilator, or dilating connector through atissue path to an external incision.

A tissue fastener can be placed at and secured (or “fixated” or “fixed”)within internal tissue of the pelvic region to support the implant andpelvic tissue that is supported by the implant. A tissue fastener can beplaced at muscle tissue of an obturator foramen (e.g., obturatorinternus muscle), tissue of an arcus tendineus or surrounding an arcustendineus, tissue of a sacrospinous ligament, tissue in a region of asacrospinous ligament, tissue of a coccyx region, tissue of a region ofan ischial spine, tissue of coccygeous muscle, tissue of iliococcygeousmuscle, tissue of a uterosacral ligament, tissue of levator muscle, orat other tissue of the pelvic region.

One embodiment of a tissue fastener is a self-fixating tip. A“self-fixating tip” in general can be a structure (sometimes referred toas a soft tissue anchor) connected to an extension portion that can beimplanted into tissue (e.g., muscle tissue, tendon tissue, or ligamenttissue) in a manner that will maintain the position of the self-fixatingtip and support the attached implant. Exemplary self-fixating tips canalso be designed to engage an end of an insertion tool (e.g., elongateneedle, elongate tube, etc.) so the insertion tool can be used to pushthe self-fixating tip through and into tissue for implantation,preferably also through an incision to reach the interior of the pelvicregion. The self-fixating tip may engage the insertion tool at aninternal channel of the self-fixating tip, at an external location suchas at a base, or at a lateral extension, as desired.

Exemplary self-fixating tips can include one or more lateral extensionsthat allow the self-fixating tip to be inserted into soft tissue and tobecome effectively anchored in the tissue. A lateral extension may bemoveable or fixed. The size of the self-fixating tip and optionallateral extensions can be useful to penetrate and become anchored intothe tissue. Exemplary self-fixating tips are described in Assignee'scopending international patent application PCTUS2007/004015, filed Feb.16, 2007, titled Surgical Articles and Methods for Treating PelvicConditions, the entirety of which is incorporated herein by reference.Other structures may also be useful.

According to exemplary embodiments, a self-fixating tip can havestructure that includes a base having a proximal base end and a distalbase end. The proximal base end can be connected (directly orindirectly, such as by a connective suture) to a distal end of anextension portion (also meaning, as used herein, a scaffold portion).The base extends from the proximal base end to the distal base end andcan optionally include an internal channel extending from the proximalbase end at least partially along a length of the base toward the distalbase end. The optional internal channel can be designed to interact with(i.e., engage) a distal end of an insertion tool to allow the insertiontool to be used to place the self-fixating tip at a location withinpelvic tissue of the patient. Embodiments of self-fixating tips alsoinclude one or more lateral extension extending laterally (e.g.,radially) from the base, such as from a location between the proximalend and the distal end, from a location at the distal base end, or froma location at the proximal base end.

A self-fixating tip can be made out of any useful material, generallyincluding materials that can be molded or formed to a desired structureand connected to or attached to an end of an extension portion of animplant. Useful materials can include plastics such as polyethylene,polypropylene, and other thermoplastic or thermoformable materials, aswell as metals, ceramics, and other types of biocompatible andoptionally bioabsorbable or bioresorbable materials. Exemplarybioabsorbable materials include, e.g., polyglycolic acid (PGA),polylactide (PLA), copolymers of PGA and PLA.

Other embodiments of tissue fasteners can be various, and can includetypes of fixed or moveable structures capable of securing an implantextension portion or an implant scaffold portion to soft tissue.According to methods described herein, the tissue fastener can bedesigned to removably engage an end of a shaft of an insertion tool,while also being attached to an end of an extension portion, and alsocapable of being covered by a sheath when engaged at the end of theshaft. Examples of tissue fasteners may include those sometimes referredto as soft tissue anchors and a self-fixating tips, and also includespring-biased fasteners that can be inserted into tissue or that maygrasp and hold tissue, fasteners that include a male component thatengages a female component (e.g., within tissue), or that involveextensions (tines or teeth) that can be extended from a delivery tool tosplay laterally into soft tissue.

Embodiments of implants and kits according to the present descriptioncan include extension portion pieces, as described, of variousconstructions. Generally, an extension portion piece can include asegment (referred to herein as a “mesh portion,” but not necessarily ofmesh) having a tissue fastener at one end. The extension portion piececan be configured to engage a support portion piece in a manner thatallows the mesh portion to provide a structure that includes anextension portion having an adjustable length. An end of the extensionportion piece can be placed through an adjusting engagement of a supportportion piece, and the end of the support portion piece that includesthe tissue fastener forms an extension portion between tissue (withwhich the tissue fastener becomes engaged) and the support portion piece(to which the extension portion is engaged at the adjustableengagement).

Embodiments of extension portion pieces used with methods and implantsdescribed herein may also include a non-mesh portion. A non-mesh portionmay be, for example a suture, a set of sutures, a tape, or processed(e.g., melted or compressed) mesh. A non-mesh portion can facilitateplacement or movement of an extension portion piece relative to asupport portion piece, e.g., through an adjusting engagement. A mesh ofan extension portion piece may be unwieldy for placing into an adjustingengagement such as a small-diameter grommet, small-dimension slot,toothed-slot, etc. A non-mesh portion can allow easier placement(threading) of an end of an extension portion piece through an apertureof an adjusting engagement by providing a less widely, integral(non-mesh), more easily managed end. A non-mesh tape, for example, maybe more easily inserted into a slot or a toothed-slot of a one-way or atwo-way adjusting engagement. A cylindrical non-mesh portion such as aflexible yet rigid plastic “rod” may be more easily inserted into around aperture such as an aperture of a grommet, compared to a loose endof a mesh material.

A non-mesh portion may allow for easier adjustment of the extensionportion piece within an adjusting element. A non-mesh can exhibitreduced cross section, and friction compared to a mesh material.Additionally, an extension portion piece made of a full length of meshmaterial can undesirably engage tissue that can stick to mesh and becomelodged in an adjusting element. A non-mesh portion can be less prone tosticking to tissue during use.

Mesh and non-mesh portions of an extension portion piece can bedimensioned to allow the mesh portion to engage an adjusting engagementwhen adjusted to a desired length and when a distal end tissue fasteneris fastened to tissue as desired. A non-mesh portion can be of a lengthto allow manipulation and adjustment of the extension portion piece.Exemplary lengths of a total extension portion piece can be in the rangefrom 4 to 10 inches, including a mesh portion and a non-mesh portion (ifpresent). For an extension portion piece that includes a mesh portionand a non-mesh portion, a mesh portion can be, for example, from 1 to 4inches in length and a non-mesh portion (e.g., polymeric rod, suture,etc.) can be, for example, from 3.5 to 5.5 inches in length.

FIG. 4 illustrates one example of a useful implant (231), having certainfeatures described herein. Support portion piece 205 can be placed,e.g., to treat anterior vaginal prolapse. Implant 200 includes supportportion piece 205 having two-way apertures (e.g., grommets or openings)204 and 206. Extension portion pieces (not shown) can be threadedloosely through each of apertures 204 and 206, respectively, to allowsubstantially free two-way movement of each extension portion piecethrough each aperture (204, 206), for adjustment. Tissue fasteners 216can be placed at opposing obturator foramen of a patient, while supportportion piece 205 is placed to support vaginal tissue. Posterior tissuesupport extension 226 is optional and may be place to support posteriorvaginal tissue. Adjusting engagements 204 and 206 may be one-wayadjusting engagements (e.g., grommets) or two-way adjusting engagements(e.g., grommets). Extension portion pieces (not shown) may include alength that is entirely mesh, or may include a mesh portion and anon-mesh portion, FIGS. 5A and 5B or otherwise described herein. Agrommet management tool as illustrated at either of FIGS. 6A and 6B, oras otherwise described herein, can be used to place a grommet on eachnon-mesh portion of such extension portion pieces. An adjusting tool maybe used to adjust position of an adjusting engagement.

Mark 217 on implant 231 includes a centerline mark and an orientationmark. The mark is on one side of the implant, e.g., to identify a topsurface of the implant relative to a bottom surface. The centerline mark217 a runs vertical (as illustrated), which is from an anterior to aposterior location on the implant, and is located to mark the centerlineof the implant piece. A portion of the mark, 217 b, perpendicular tocenterline mark 217 a, indicates a particular side of the implant, whichas illustrated is a patient-left-side of the implant. This may beuseful, for example, to confirm correct orientation of the implant suchas that the correct side of the implant is being placed upward.

Exemplary dimensions of an implant as shown at FIG. 4 can be: length A,from 5 to 7 centimeters, e.g., from 5.5 to 6.5 centimeters; length B,from 10 to 12 centimeters, e.g., from 10.5 to 11.5 centimeters; lengthC, from 5.5 to 7.5 centimeters, e.g., from 6 to 7 centimeters; length D,from 3.5 to 5.5 centimeters, e.g., from 4 to 5 centimeters; length E,from 2 to 4 centimeters, e.g., from 2.5 to 3.5 centimeters; and lengthF, from 4 to 6 centimeters, e.g., from 4.5 to 5.5 centimeters.

FIG. 5A illustrates an example of an extension portion piece(alternately referred to herein as a “fixation arm”) that includes amesh portion and a non-mesh portion. Extension portion piece 110includes mesh portion 114 and non-mesh portion 112, in the form of twosutures 113. Tissue fastener (e.g., a self-fixating tip) 116 is attachedto a distal end of mesh portion 114. Sutures 113 are attached to aproximal end of mesh portion 114, such as by knots. Non-mesh portion 112is illustrated to be in the form of two sutures, but may alternately bymore or fewer sutures, such as one suture, or three sutures, optionallytied or braided. Still alternate forms of non-mesh portion 112 may be apolymeric tape, a narrow fabric, or the like, any of which can beselected to be easily threaded through an aperture of a desiredadjusting engagement.

FIG. 5B illustrates another example of an extension portion piece(alternately referred to herein as a “fixation arm”) that includes amesh portion and a non-mesh portion. Extension portion piece 100includes mesh portion 104 and non-mesh portion 102. Tissue fastener(e.g., self-fixating tip) 106 is attached to a distal end of meshportion 104. Polymeric (e.g., polypropylene) rod 102 is attached to(preferably integral to) a proximal end of mesh portion 104. Polymericrod 102 can be formed by any method and may be integrally attached tomesh portion 104, or attached by any technique. As an example, polymericrod 102 may be prepared by starting with a length of mesh material thatis integral to mesh portion 104. The length of mesh can be heat treatedat a desired melting temperature (according to the type of polymer ofthe mesh) to melt the mesh into a polymeric rod having stiff yetflexible mechanical properties. For polypropylene, a desiredheat-treating temperature may be in the range from 450 to 520 degreesFahrenheit. Polymeric rod 102 can be of useful dimensions, such as alength in the range of about 3.5 to 5.5 inches and a width dimension(e.g., diameter) useful to engage a dilator, e.g., about 1/16 of aninch, or from about 1 to 4 millimeters.

Optionally, and as illustrated at FIG. 5B, proximal end 109 of polymericrod 102 can be shaped to accept or matingly engage an end of agrommet-management tool, such as a polymeric rod, that can facilitateplacement of a grommet or other adjusting engagement onto a proximal endof a non-mesh portion of an extension portion piece. Absent some type ofgrommet-management tool, a user of an extension portion piece such asextension portion piece 100, may place a grommet (e.g., a one-waygrommet) onto a proximal end of a non-mesh portion by hand, usingfingers. This can be clumsy, especially in potentially confined or deeplocations of a pelvic region. A grommet management tool holds one ormultiple grommets. An end of the grommet management tool can engage aproximal end of a non-mesh portion of an extension portion piece in amanner to allow the end of the grommet management tool to align and mateagainst the proximal end of the extension portion piece. Once the endsare engaged, a grommet can slide from the grommet management tool,directly onto the proximal end of the non-mesh portion of the extensionportion piece.

A grommet management tool may contain a single grommet, or multiplegrommets, and can be used to transfer the one or multiple grommets ontomultiple different extension portion pieces of a single or multiplepelvic implants. Advantageously, a grommet management tool can ensurethat control of a grommet (or other adjusting engagement) and a locationof a grommet are not lost during a surgical procedure, and a grommet canbe prevented from becoming a free-standing, separate piece with thepotential of becoming lost during a surgical procedure.

FIG. 6A illustrates grommet management tool 120, which is a rod, such asa polymeric (e.g., polypropylene) rod with a diameter that matches adiameter of polymeric rod 102. One-way (alternately two-way) grommets124 are aligned along a length of grommet management tool 120. Distalend 124 includes channel or bore 122 that is complementary tocylindrical extension 108 at proximal end 109 of extension portion piece100. These complementary surfaces can be engaged to allow transfer of agrommet from tool 120 to polymeric rod 102.

In use, non-mesh portion 102 of extension portion piece 100 can bepassed through an adjusting engagement of an implant. The implant andextension portion piece can be manipulated and placed as desired, suchas at locations within a pelvic region. Channel 122 of grommetmanagement tool 120 can be placed over cylindrical extension 108, and agrommet 124 can be slid in direction B (see FIG. 6A) and transferredfrom grommet management tool 120 onto proximal end 109 of extensionportion piece 100. One-way grommets 124 move easily along an extensionportion piece in direction B, and are inhibited from moving in adirection opposite of direction B when placed on a mesh portion such asmesh portion 104. Once placed onto extension portion piece 100, grommet124 can slide to engage mesh portion 104, and contact the adjustingengagement of the tissue support portion or support portion piece tosecure a relative position of mesh portion 104 to the tissue supportportion or support portion piece, e.g., to fix a length of an extensionportion of mesh portion 104.

A grommet management tool such as tool 120 can be made of a plastic,metal, or other useful material. As an example, a grommet managementtool can be prepared in the same manner used to make a polymeric rodnon-mesh portion 102, such as by melting a length of mesh and molding toform a polymeric rod. Other methods can also be used, such as byextruding, injecting molding, etc.

As illustrated, the engagement between distal end 124 of grommetmanagement tool 120, and proximal end 109 of non-mesh portion 102,includes complementary cylindrical surfaces. Other engagements can alsobe useful, such as complementary conical surfaces, square surfaces, etc.

Optionally, a feature of a non-mesh portion of an extension portionpiece, or of a grommet management tool, may include a feature thatallows a one-way grommet to pass only if the one-way grommet iscorrectly oriented for movement in a desired direction. An example ofthis feature can be a shoulder or notch located at a proximal end of anon-mesh portion of an extension portion piece (or, alternately, at adistal end of a grommet management tool).

Referring to FIG. 6B, grommet management tool 130 engages proximal end132 of an extension portion piece. The engagement includes complementaryconical surfaces 134 to allow alignment and mating between the two ends.Notch 140 and shoulder 142 allow one-way grommet 136 to transfer fromtool 130 onto non-mesh portion 132, because grommet 136 is oriented in adirection to allow movement in direction C and inhibit movement in adirection opposite of direction C. Notch 140 and shoulder 142 preventone-way grommet 138 from transferring onto non-mesh portion 132. Grommet138 is oriented in a direction to allow movement in the directionopposite of direction C and not in direction C. Teeth 139 of grommet 138would engage shoulder 142 and stop grommet 138 from moving past shoulder142 in direction C. Notch 140 and shoulder 142 are illustrated to belocated on non-mesh portion 132, but alternately could be included ongrommet management tool 130.

A system as described also includes an insertion tool that generallyincludes a handle and a shaft. The shaft can be a solid structure suchas a solid needle that is optionally curved in two or three dimensions.The distal end of the needle can include a surface that engages a tissuefastener by fitting inside a channel in a base of the tissue fastener,e.g., as with embodiments of self-fixating tips. Alternately, a shaftcan include a hollow center such as that of a trocar, or a moveablemechanism that can engage a self-fixating tip by grasping or othermechanical engagements. Various different types of surgical tools,including insertion tools, may generally be useful to engage and place atissue fastener secured to an extension portion (or, as describedherein, a scaffold portion) of an implant as described. Various types ofinsertion tools are known, and these types of tools and modificationsthereof can be used according to the present description to install animplant.

Examples of useful insertion tools include those types of tool thatgenerally include a thin elongate shaft (e.g., needle); a handleattached to one end (a proximal end) of the shaft; and an optionaldistal end (or “tip”) of the shaft adapted to engage a tissue fastenerconnected to extension portion (including a scaffold portion). Theneedle can facilitate placement of the distal end of the extension orscaffold portion at a desired anatomical location that may be internalor through a tissue path to an external incision.

Exemplary insertion tools for treatment of incontinence and vaginalprolapse are described, e.g., in U.S. patent application Ser. Nos.10/834,943, 10/306,179; 11/347,553; 11/398,368; 10/840,646; PCTapplication number 2006/028828; and PCT application number 2006/0260618;each of which is incorporated herein in its entirety by reference. Toolsdescribed in these patent documents are designed for placement of animplant in a pelvic region for the treatment of prolapse, male or femaleincontinence, etc.

Exemplary insertion tools can be similar to or can include features oftools described in the above-referenced patent documents. For useaccording to certain methods described herein, those insertion tools maybe modified, such as to allow the insertion tool to be used to place aself-fixating tip through a vaginal or a medial incision, to engagetissue within the pelvic region. The insertion tool can be designed,shaped, and sized, to include an elongate shaft that may be straight orthat may be curved in two or three dimensions, that can be insertedthrough a vaginal incision (for female anatomy) or through a perinealincision (for male anatomy), and extend from that incision to or throughpelvic tissue for placement of a distal end of an extension portion.

Another tool for optional use in a method as described, such as methodsthat involve an adjusting mechanism, is an adjusting tool. An adjustingtool can be an elongate tool that includes a distal end that engages anadjusting mechanism, to manipulate and optionally cause movement of theadjusting mechanism relative to a portion of implant. FIGS. 7A and 7Bshow side and top views of adjusting tool 170, useful for moving anadjusting engagement such as a grommet along a length of a segment of animplant such as a segment of an extension portion or a scaffold portion.Tool 170 includes elongate shaft 172 and distal end 174. Slot 176 atdistal end 174 can be slid past a segment of implant to place a segmentof implant at a location within aperture 179. Aperture 179 is defined inpart by opposing arms 178 (illustrated to be curved, but optionallystraight, angled, etc.) that extend laterally and optionally distallyfrom a distal end of shaft 172, to define aperture 179 and slot 176.Bottom surfaces of arms 178 can be used to apply pressure to anadjusting engagement (e.g., grommet) located on the segment of implant,and move the grommet, preferably in a direction along the segment ofimplant to adjust a length of an extension portion or scaffold portion.Slot 176 is optional, and distal end 174 could alternately include aclosed aperture through which a portion of implant could be threadedplace distal end 174 in contact with an adjustable engagement.

The dimensions of the slot (optional) and aperture can be useful toengage a segment of implant. A slot, for example, may define an openingthat is in the range from 0.5 to 1.2 centimeters, e.g., from 0.5 to 1.0centimeter. An aperture may have the same or similar dimensions, or maybe the same width or wider than the slot, such as having a diameter inthe range from 0.5 to 1.2, e.g., 0.5 to 1.0 centimeter. Surfaces forengaging an adjusting engagement may correspond to a size of surfaces ofthe adjusting engagement, such as having surfaces that match surfaces ofa flange of a grommet.

Another embodiment of adjusting tool is shown at FIGS. 8A and 8B. Thisembodiment of adjusting tool 170 includes features of tool 170 asillustrated at FIGS. 7A and 7B, and also includes an optional second setof arms around aperture 179, located in alignment with arms 178. FIGS.8A and 8B show side and top views of this embodiment of adjusting tool170. In addition to arms 178, defining features and surfaces asdescribed, this embodiment of tool 170 includes a second set of arms,184, that are aligned with arms 178 and that define additional length ofaperture 179.

Still referring to FIGS. 8A and 8B, optional arms 186 are structured toprevent tissue from becoming lodged inside of an adjusting engagement(e.g. a grommet) during movement of grommet 32 in a direction N along asegment of implant. For instance, when an adjusting tool is used to movea grommet along a segment of mesh implant, within a patient, tissue maycome into contact with the mesh or the grommet and (absent arms 186) cantend to be forced into the aperture of the grommet. Arms 186 becomelocated on the side of the grommet that moves into tissue, and deflectand block tissue from entering an aperture of the grommet. Alternately,or additionally, second arms 186 can be used to move a two-way grommetin a direction opposite of the direction of movement provided by arms178; i.e., this embodiment of an adjusting tool allows for a two-waygrommet to be moved in two different directions (distally, andproximally) along an implant segment.

In use, slots 176 and 184 at distal end 174 can be slid over a segmentof implant to place a segment of implant at a location within aperture179 (defined by and between sets of arms 178 and 186). FIG. 10A showsthat bottom surfaces 182 of arms 186 can deflect and block tissue fromentering an aperture of adjusting engagement 192, which may be, e.g., aone-way or a two-way grommet used to adjust the location of implantportion 190 relative to implant segment 198, which includes tissuefastener 196 placed within tissue 194.

In use, embodiments of implants as described can be implanted accordingto methods that include placement of a tissue support portion of animplant at a location to support pelvic tissue, and placement of atissue fastener attached to an extension portion of an implant (e.g., anextension portion piece), including optional use of an insertion toolthat includes a sheath as described. A method may include steps such asengaging a tissue fastener with the distal shaft end, placing a sheathover the shaft and engaged tissue fastener, and inserting the shaft andengaged tissue fastener into a patient with the sheath placed over theshaft in the covered configuration. The sheath may engage an optionalmechanical stop to maintain the position of the sheath in the coveredconfiguration. The mechanical stop may be removed to allow the sheath tomove (e.g., slide in a proximal direction along the shaft) to anuncovered configuration that uncovers the tissue fastener. The tissuefastener can then be fastened to tissue of a patient, e.g., soft tissueof a pelvic region. If the tissue fastener is a self-fixating tip, theself-fixating tip can be fastened to the soft tissue by using the handleand shaft to push the self-fixating to into the soft tissue. If thetissue fastener fastens to tissue by another mechanism, such as bymechanical grasping, optionally using a shaft that opens or closes agrasping mechanism of the tissue fastener, then the tissue fastener canbe caused to engage tissue by manipulation of an actuator or otheractuating mechanism to secure the tissue fastener to tissue.

One or more extension portions and optional scaffold portions are placed(by use of an insertion tool with a sheath, or otherwise) for use insupporting the tissue support portion. For example, a tissue fastener ata distal end of an extension portion can be placed at internal tissue ofthe pelvic region such as muscle, ligament, tendon, fascia, bone, etc.Alternately, an extension portion may include a connector, forconnecting to a tool that pulls the connector and extension portionthrough a tissue path leading to an external incision (e.g., at anexternal perirectal region, or through an obturator foramen and to anexternal incision at an inner thigh). As yet another alternative, anextension portion may not include a connector or a self-fixating tip butmay be connected to tissue or led through a tissue path internal to thepatient, or may be passed through a tissue path and an externalincision. Optionally, a tissue fastener at a distal end of a scaffoldportion can be connected to internal tissue of the pelvic region such asmuscle, ligament, tendon, fascia, bone, etc. Alternately oradditionally, an end of a scaffold portion can also be attached to atissue support portion or an extension portion of an implant. Anextension portion or a support portion piece can be attached to thescaffold portion at a location between the ends of the scaffold portion.

Embodiments of methods can be performed using a medial incision such asthrough a vaginal incision (for female anatomy) or perineal incision(for male anatomy), and by use of an insertion tool (e.g., any insertiontool described herein) that engages a distal end of the extensionportion (such as by engaging a tissue fastener) and passes the distalend to a desired location within a pelvic region of a patient.

An end of an extension portion or scaffold portion can be attached toany desired tissue of the pelvic region, or passed through a desiredtissue path to an external incision. To attach a distal end of anextension portion or scaffold portion to tissue, a tissue fastener canbe attached at the end of the extension or scaffold portion. Duringinstallation of the implant, the tissue fastener can be attached to anydesired tissue, for example soft tissue such as a muscle (e.g., of theobturator foramen, obturator internus, obturator externus, levator ani,coccygeous, iliococcygeous); ligament such as the sacrospinous ligamentor surrounding tissue; tendon such as the arcus tendineus or surroundingtissue (e.g., a region of the arcus tendineus, see WO 2007/016083,published Feb. 8, 2007, and entitled “Methods and Symptoms for Treatmentof Prolapse,” the entirety of which is incorporated herein byreference); including tissue at or near an ischial spine, e.g., at aregion of an ischial spine.

The described implants and tools can be combined into kits (e.g.,“systems”) that contain multiple different combinations of implant,implant pieces, insertion tools, and other tools as described herein.Any of the implants can be in a kit with insertion tools, extensionportion pieces, support portion pieces, adjusting tools, grommetmanagement tools, and tissue fasteners, in any combination. FIG. 9illustrates such combinations. Kit 500 includes support portion piece502, two extension portion pieces 504 (each shown to have a mesh portionand a non-mesh portion), sheath 520 for use with insertion tool 510,insertion tool 530, optional adjusting tool 506, and optional grommetmanagement tool 508.

Sheath 520 is in the form of a self-supporting polymeric (e.g.,polypropylene) tube having proximal end 522, distal end 524, andsidewall aperture 526. Insertion tool 510 can be as described, e.g., asillustrated at FIGS. 1A, 1B, 1C, 1D, 2A, and 2B. As illustrated,insertion tool 510 includes handle 507, including recess 532, and lever528 including pin (mechanical stop) 530. A distal end of shaft 511 ofinsertion tool 510 engages tissue fasteners 512, of extension portionpieces 504, e.g., for placing tissue fasteners 512 at a posteriorlocation of a pelvic region such as at a sacrospinous ligament. Aperture526 of sheath 520 engages pin 530 when sheath 520 covers shaft 511 in acovered engagement, wherein proximal end 522 partially enters recess532. In an uncovered engagement, proximal end 522 extends further intorecess 532 to uncover the distal end of shaft 511.

Extension portion pieces 504 include a mesh-portion and a non-meshportion, but entirely mesh extension portion pieces could be used.Optional adjusting tool 506 can be as described, e.g., as illustrated atFIGS. 7A and 7B, or 8A and 8B. Optional grommet management tool 508 canbe as described, e.g., as illustrated at FIG. 6A or 6B. End 514 ofgrommet management tool 508 can matingly engage ends 516 of non-meshportions of extension portion pieces 504, such as at cylindrical bores(shown in shadow).

Insertion tool 530 includes a handle and a shaft, the distal end of theshaft being capable of engaging tissue fasteners 513 of implant supportportion piece 502, to allow insertion tool 530 to place tissue fasteners513 transvaginally, at an anterior location of the pelvic region, e.g.,each at an opposite location of an obturator foramen.

Support portion piece 502 can be designed to support posterior vaginaltissue, anterior vaginal tissue, vaginal vault tissue, or another pelvictissue, and can include optional features such as additional extensionportions or scaffold portions or additional adjusting engagements (notshown). For example support portion piece 502 can comprise a supportportion piece or implant as described or illustrated herein. Apertures518 can be one-way adjusting engagements or two-way adjustingengagements.

In use, insertion tool, 510, extension portion piece 504, and sheath520, can be used by initially placing tissue fastener 512 in contactwith distal end 515 of tool 510. As shown at FIG. 10A, sheath 520 canthen be placed over shaft 511 and extension portion piece 504 (each iswithin sheath 520). Proximal end 522 of sheath 520 contacts pin 530,preventing proximal end 522 from fully entering recess 532 of handle507. This is the covered configuration, wherein distal end 524 of sheath520 covers tissue fastener 512 engaged with distal end 515 of shaft 511of insertion tool 510. The covered configuration can be used forinserting a tool, with engaged tissue fastener and extension portion(e.g., extension portion piece), into a patient, e.g., through atransvaginal or other incision, to place tissue fastener 512 at alocation in the body near a fixation site.

Once near a fixation site the tool and sheath can be converted to theuncovered configuration to allow tissue fastener 512 to engage tissue.FIG. 10B illustrates the uncovered configuration wherein distal end 524of sheath 520 does not cover tissue fastener 512 engaged with distal end515 of shaft 511 of insertion tool 510; pin 530 has been moved fromengaging proximal end 522, and proximal end 522 has been moved intorecess 532. In this uncovered, tissue fastener 512 can engage tissue ata fixation site.

An example of a method as described herein for treating vaginalprolapse, e.g., anterior or posterior vaginal prolapse (includingvaginal vault prolapse), can include placing a tissue support portion attissue of the anterior or posterior vagina or vaginal vault, and fixingone and optionally two posterior extension portions extending from thetissue support portion to a sacrospinous ligament, then securing twoanterior extension portions to opposing obturator foramen. Placement ofone or all of the extension portions may be performed using an insertiontool that incorporates the use of a sheath as described herein.

An example of a system according to the present description, includingan implant and insertion tool for treating vaginal prolapse, can be asfollows.

The system can be used to treat or repair vaginal prolapse withoutexternal needle passes, by use of a single, transvaginal incision. Oneembodiment of this type of system can be useful to treat posteriorvaginal prolapse by placement of extension portions of an implant atlocations that include a sacrospinous ligament, a coccygeus muscle, orboth. The implant can be implanted, fixated, and adjusted, as desired,transvaginally, via a single vaginal incision. Unlike other similarsystems and methods this described embodiment can be implanted in thebody without external trans-gluteal needle passes and is, thus, lessinvasive.

The system generally includes fixation arms (extension portion pieces)(e.g., as illustrated at FIG. 5B, a center graft (a support portionpiece) (e.g., as illustrated at FIG. 4), a delivery device (insertiontool) (e.g., as illustrated at FIG. 1A, 1B, 1C, 1D, 2A, or 2B), andadjusting engagements. These tools and implant pieces can be part of asystem as shown at FIG. 9.

A fixation arm can fixate to an internal fixation site, guide the centergraft within the body, and aid in internal adjustment of the centergraft. Each fixation arm generally includes a stem (non-mesh portion), amesh segment (mesh portion), and a fixation element (tissue fastener).Components of a fixation arm can be made of polypropylene or anymaterial now known to or yet developed by a person skilled in the art.

FIG. 5B shows an example of a fixation arm that includes a solidpolymeric stem (102). A distal end of stem 102 can be over-molded on anend (proximal end) of mesh segment 104. Alternately, stem 102 and meshsegment 104 can be made of a single piece of polymeric material. Afixation element (106) can be over-molded on another (distal) end orportion of mesh segment 104. A proximal end of the stem (109) can beused by a physician during surgery to guide placement of and manipulate,relative to each other: loose eyelet (e.g., a one-way adjusting grommet)of the center graft, the locking eyelet holder (e.g., a grommetmanagement tool), the locking eyelets (e.g., one-way adjusting grommet),and the accessory tool (adjusting tool). The stem can allow the looseeyelets of the center graft and the locking eyelets to be transferredinto the body of a patient without encountering tissue-catching issues;e.g., a stem may extend from an incision after placement of a fixationarm, and the stem may be threaded through the loose eyelet outside ofthe body and away from the confined surgical site. The mesh segment(mesh portion) of the fixation arm can allow free passage of a looseeyelet while permitting at least one locking eyelet to move in onedirection to secure the loose eyelet in place. The fixation element canallow strong acute fixation in the sacrospinous ligament or any othersoft tissue.

The center graft generally comprises a graft portion (e.g., mesh orbiologic material) and optional loose eyelets. The graft portion can bemade of extra-light polypropylene (ELPP), a porcine graft, any materialnow known to or yet developed by a person skilled in the art for use inbiological implants, or combinations of materials. One loose eyelet canbe over-molded on a side of the graft portion and another loose eyeletcan be over-molded on another or opposite side of the graft portion. Theloose eyelets can be used to allow a physician to translate the centergraft into and out of the body for proper positioning. In oneembodiment, the positioning and repositioning of the center graft isaccomplished on the stem prior to being secured with the lockingeyelets.

According to this or other implants, implant pieces, or systems,portions of the mesh arms (e.g., extension portions) can have one ormore rolls or folds disposed along a length thereof that are suturedprior to system implantation and held together, e.g., by sutures,staples, adhesive, or another fastener. If the implant is too tight, aphysician or other medical staff can cut the sutures holding the rollsor folds together invivo to increase a length of one or more of the mesharms. The increased length loosens the center graft.

The locking system (adjusting mechanism) generally includes the lockingeyelets (e.g., one-way adjusting grommets), an optional locking eyeletholder (grommet management tool), loose eyelets (e.g., two-way adjustinggrommets), and an optional accessory tool (e.g., adjusting tool). Allcomponents of the locking system can be made of polypropylene, or anymaterial now known to or yet developed by a person skilled in the art.The locking eyelet can be a one-way tensioning device that, once engagedwith the mesh segment of the fixation arm, permits only increasedtensioning of the center graft.

The locking eyelet can associate with a loose eyelet of the center graftto fixate the center graft on the mesh segment of the fixation arm. Thelocking eyelet can feature generally inwardly radiating teeth that canbe oriented at an angle to allow translation along the fixation arm inone or both directions along the stem of the fixation arm and to preventtranslation in a direction toward the stem of the fixation arm onceengaged with the mesh segment (e.g., mesh portion). The locking eyeletholder, capable of being manipulated by a physician or other medicalstaff, keeps the locking eyelets correctly oriented and can mate with anend of the fixation arm to translate the locking eyelets when necessary.Loose eyelets can be over-molded on the center graft. Each loose eyeletcan be loaded on the proximal end of the stem of the fixation arm andcan be translated on the fixation arm for proper positioning of thecenter graft. The accessory tool can aide a physician or other medicalstaff when translating the loose eyelets of the center graft and thelocking eyelets on the fixation arm. The accessory tool can beespecially helpful in small body cavities or hard-to-reach locationswithin a patient, such as but not necessarily in a pelvic region.

The delivery device (insertion tool) generally includes a shaft such asa solid needle, and a handle. The needle generally comprises a solidlength of shaft and a tip at the distal end, wherein the tip engages afixation element (e.g., tissue fastener, such as a self-fixating tip).The needle can transport the fixation element of the fixation arm to adesired fixation site (e.g., at soft tissue of a pelvic region) and canperform placement of the fixation element in soft tissue or tissueselected by the physician or other medical staff.

The following can be a method of implantation of the above system, fortreating vaginal prolapse. This method can be performed with aninsertion tool that involves a sheath as described, or without a sheath:

1. Determine vaginal apex and each lateral uterosacral dimple point.

2. Use preferred incision method through posterior vaginal wall. Usefull thickness dissection through recto-vaginal fascia. Leaveapproximately 2 cm of vaginal wall distal to apex intact for attachment.

3. Dissect toward the ischial spine and palpate the ischial spine withthe index finger.

4. Begin blunt dissection in the medial direction along the sacrospinousligament. Dissect 2-3 finger breadths towards the sacrum.

5. Perform steps 3-4 for contralateral side.

6. Insert a fixation element of a fixation arm onto a needle tip of adelivery device.

7. Grasp handle of delivery device with left hand.

8. To locate area of fixation of patient right, palpate the sacrospinousligament two-finger breadths medially from the ischial spine (at least 2cm medially from the ischial spine).

9. Insert both the index and middle finger into the vaginal cavity.

10. Place first bend of needle at fixation point and at the tip of themiddle finger.

11. Drive the fixation element into the ligament until the needle tip isinserted up to the first bend.

12. Remove needle tip from the fixation element by placing finger atarea of implantation and pulling back gently on needle shaft until itdisengages from fixation element.

13. Carefully remove the delivery device though incision and outintroitus.

14. For patient left, perform steps 6-13, switching to opposite side forall directional instructions.

15. Determine the correct orientation of the center graft. Locate looseeyelets on the center graft. Slide the stem of one of the fixation armsexiting from the introitus through its corresponding loose eyelet of thecenter graft. Slide the stem of the other fixation arm exiting from theintroitus through its corresponding loose eyelet of the center graft.

16. Load the accessory tool on the proximal end of the stem of one ofthe fixation arms.

17. Translate the accessory tool a short distance on the fixation armtoward the fixation site. By this action the center graft will be pushedinto the pelvic cavity. Remove the accessory tool from the fixation arm.

18. Repeat steps 16-17 for the other fixation arm.

19. Repeat steps 16-18 until desired position of the center graft hasbeen achieved. To loosen the center graft, grab the center graft andpull towards the introitus.

20. Once adjustment of the center graft is final, locate the lockingeyelet holder. Align and engage the end of the holder onto the proximalend of a stem of one of the fixation arms. Load one locking eyelet onthe fixation arm and disengage the locking eyelet holder.

21. Repeat step 20 to load one locking eyelet on the other fixation arm.

22. Reload accessory tool on proximal end of the stem of one of thefixation arms. Proceed to translate accessory tool on fixation armtoward fixation site until locking eyelet reaches the loose eyelet onthe center graft. Palpate to verify locking eyelet rests against surfaceof center graft. If not, readjust with accessory tool. Note: in at leastone embodiment of the described methods (if locking eyelet is a one-wayadjusting grommet) a locking eyelet cannot be reversed once its teethcome into contact with a portion of the mesh segment that is proximalfixation arm.

23. Repeat step 22 for other fixation arm.

24. Trim mesh segment at least 1 cm proximal to the locking eyelet.Verify that discarded stems contain mesh on its distal end. If not, trimaway remaining stem from the mesh segment in vivo.

25. Continue with repair of posterior defects, if needed. Avoid placingany tension while suturing the mesh. Close recto vaginal fascia over themesh and close vaginal incision.

Embodiment of methods that incorporate these steps can treat cystocele,rectocele, enterocele, vault prolapse, and/or any pelvic dysfunctionrelating to rectal, vaginal, or bladder issues.

Embodiments of fixation elements can be over-molded on the free end ofeach mesh arm. The fixation element can have a bore to receive theneedle of a delivery device. During a surgical procedure, the fixationelement or the needle can dilate the tissue. The fixation element canthen be attached at a location at a posterior pelvic region, such as anyof a: sacrospinous ligament, coccygeus muscle, iliococcygeus muscle,arcus tendineus (white line), fascia at the ischial spine, puborectalismuscle, piriformis muscle, fascia at the obturator canal, or anylocation on the levator ani. Other fixation sites are also considered tobe within the spirit and scope of the invention and the above listshould not be considered limiting.

Embodiments of delivery devices (insertion tools) can generally includea shaft (e.g., a solid needles shaft), a handle, and a distal tip at theend of the shaft that engages a fixation element. The needle can providetransport of the fixation element of the center graft to the targetfixation site and can perform placement of the fixation element intissue. The needle can have many possible shapes, depending where thefixation element is intended to fixate. For example, three-dimensionallycurved helical-shaped needles can be used near the white line.Two-dimensionally curved sickle-shaped needles can be used near thesacrospinous ligament area. In one embodiment, the needle can have asliding component that pushes the needle and the fixation element intothe tissue. The sliding component can be a needle-sub-needle combinationwith the sub-needle having a smaller diameter cross-section than theneedle. The sub-needle can be disposed in a cavity in the needle or itcan be disposed adjacent to and travel generally parallel with alongitudinal axis of the needle. An actuator can be disposed on theneedle to move the sub-needle between a retracted position and anextended position, with the extended position being used for placementof the fixation element.

The sliding component can also be disposed on a finger tool as well. Inone embodiment, the finger tool includes a receptacle having a shapeadapted to receive a finger or thumb of a physician. A needle or uprightmember having enough rigidity for successful placement of the fixationelement can be disposed to and extend generally away from thereceptacle. The fixation element can then be disposed on (engage) a freeend of the upright member (e.g., needle). The upright member can havingany size and shape necessary for fixating the fixation element into thetissue. For example, the upright member can be generally straight,curved, hooked, or angled.

In particular embodiments, the system can include support of the apicalportion of the vagina. The inferior aspect of the center graft canfixate at the sacrospinous ligament. The shape of the center graft canbe modified to accommodate the new fixation site and to optimizestructural support of the anterior vaginal compartment.

Another embodiment of a system generally can include a center graft,fixating arms, a delivery system (insertion tool) including a sheath, alatch-and-release mechanism for engaging the sheath with the insertiontool, and optional accessory tool or grommet management tool.

Edges of a center graft can be made of any material now known to or yetdeveloped by a person skilled in the art. Edges of the center graft canbe curved to reduce curling under tension. The shape of the center graftcan be tailored for centering and orientation. The center graftgenerally comprises a superior aspect (sometimes referred to as ananterior portion), an inferior aspect (sometimes referred to as aposterior portion), and optionally a graft tail. The superior aspect canfixate through extension portions at the obturator internus muscle. Thesuperior aspect can include fixation elements, one on each side. Theinferior aspect can fixate through extension portions at or near thesacrospinous ligament. Although generally specific fixation sites arenoted, those skilled in the art realize that other fixation sites arealso possible and should be considered within the spirit and scope ofthe invention. The inferior aspect can preferably include lockingeyelets, one on each side. The locking eyelet can associate with a looseeyelet of the center graft to fixate the center graft on the meshsegment of the fixation arm. The locking eyelet can feature teeth thatcan be oriented at an angle to allow translation along the fixation armand to prevent translation in the opposite direction once engaged withthe mesh segment of the fixation arm. The graft tail can be trimmedwithout negatively affecting its load-bearing portion. The angle of theinferior attachment tab can approximate the angle between the meshorientation and the sacrospinous ligament attachment point.

The delivery system generally comprises an inferior delivery device(insertion tool) and a superior delivery device (insertion tool). Theinferior delivery device generally comprises a needle, a sheath, ahandle, and optional a latching-and-release mechanism (e.g., as doestool 510, with shaft 520, of FIG. 9). The needle is used to transportand fixate the fixation element of a fixation arm to the sacrospinousligament or any other desired fixation site. A superior delivery devicemay include a sheath, or may include a needle without a sheath (as doestool 530 of FIG. 9.

A sheath can perform at least three functions. First, a sheath canshield the fixation arm (including the tissue fastener) during deliveryto minimize the possible inconvenience of the fixation element (tissuefastener) falling off or the fixation element getting caught on tissue.Second, a sheath can protect the physician's glove and finger fromsnagging on the fixation element during delivery. Third, a sheath canprovide a hard stop against over-insertion of the fixation element intothe tissue.

The handle of an insertion tool adapted for use in conjunction with asheath can feature a latch-and-release mechanism, which includes amechanical stop, to hold the sheath secure to the handle of the inferiordelivery device and to prevent premature exposure of the fixationelement during deployment deep inside the pelvis. The latch-and-releasemechanism releases the sheath prior to fixation element insertion intosoft tissue (e.g., sacrospinous ligament, coccygeus muscle, levator animuscle, obturator foramen, etc.). A sheath in conjunction with a latch-and release mechanism (and optional handle recess) can also control thedepth of fixation element insertion into soft tissue. Thelatch-and-release mechanism can be a lever generally comprising a rigidbar and a fulcrum. (Other options located on an insertion tool handle,shaft, or elsewhere, are also possible, as will be appreciated.) Therigid bar can feature a thumb-engaging portion and a sheath engagingportion (e.g., mechanical stop, pin, or “trigger-latch”) at oppositeends from one another. At rest, the sheath-engaging portion engages orabuts with the sheath to hold the sheath secure to the handle. When thethumb-engaging portion is depressed, the rigid bar can pivot on thefulcrum causing the sheath-engaging portion to disengage with thesheath.

An example of an inferior delivery needle, including a sheath, caninclude one or more features such as: a leading edge of trigger latch isangled, allowing the sheath to raise the trigger latch as the sheathpresses against the trigger latch during a locking procedure; when thesheath reaches a desired locking position, the latch drops down toengage an aperture in a sidewall at a proximal end of the sheath,restricting the sheath from moving forward or backward; depth limitingstop (e.g., a length of a recess in a handle) limits the sheath fromretracting too far into the handle, thus limiting the length of needletip exposed past the sheath and inserted into the tissue; the distancefrom the latch stop to the depth limiting stop (e.g., approximatelydistance d of FIGS. 1A and 1B) is the desired depth limiting distance.

A superior insertion tool can include a needle (such as a solid metalneedle) and preferably a handle; the superior insertion tool canoptionally include a sheath. The needle can be used to transport andfixate the fixation elements of the center graft to the obturatorinternus muscle. The needle can be curved to allow for direct approachto the muscle. The needle can feature a flat surface on its tip thatcorresponds to a surface of a fixation element, to prevent rotation ofthe fixation element and to control orientation of the fixation element(e.g., and tines or extension portions of the fixation element) withrespect to the muscle fiber.

The following can be a method of implantation of the above system,including an inferior insertion tool that works in conjunction with asheath, and a superior insertion tool that does not require a sheath:

1. Load a fixation element of the center graft onto the needle tip ofthe superior delivery device (e.g., a fixation element 513 of animplant, and delivery device 530, illustrated at FIG. 9).

2. Aim the needle toward the obturator internus muscle.

3. Track the needle along the posterior surface of the ischiopubic ramusin an arching motion.

4. Continue to advance the fixation element in an arching motion untilthe obturator internus muscle is penetrated by the fixation element.

5. Repeat steps 1-4 for contra-lateral side.

6. Load the fixation element of a fixation arm (e.g., 504 of FIG. 9)onto the needle tip of the inferior delivery device (e.g., 510 of FIG.9).

7. Insert the needle and engaged fixation element into the proximal endof the sheath (e.g., sheath 520 of FIG. 9).

8. Slide the sheath over the needle and fixation arm, making sure not todislodge the fixation element by inserting the distal needle end andengaged mesh arm into a proximal end of the sheath. Slide the sheathdown the needle until a proximal end of the sheath engages with thelatch-and-release mechanism on the handle. Verify the sheath is secureand the needle tip does not protrude from the distal end of the sheath.

9. Locate the sacrospinous ligament by palpation.

10. While keeping the index finger on the ligament, guide the sheath tipalong and lateral to the finger, toward the sacrospinous ligament.

11. Place the tip of the sheath to contact the sacrospinous ligament.Release the latch-and-release mechanism and allow the sheath to slideinto the recess, toward the handle, to uncover the fixation element(i.e., take the uncovered configuration). Keeping the trigger depressed,drive the fixation element into the ligament. The sheath will prohibitthe needle from getting too deep into the ligament.

12. Remove the needle and sheath from the area of implantation bypulling back gently on the needle until the needle disengages thefixation element. Carefully remove the needle assembly through theincision and out of the introitus. If the sheath does not retract withthe needle, gently remove the sheath through the incision and out of theintroitus.

13. Repeat steps 6-13 for contra-lateral side.

14. Locate one-way adjusting eyelets on the graft. Slide each eyeletover the stem of a corresponding fixation arm exiting from theintroitus. (These steps involve an implant piece that includes one-wayadjusting eyelets; optionally, a two-way adjusting eyelet may be placedon an implant piece, held in place with a one-way adjusting eyelet, asdescribed elsewhere herein.)

15. Load the accessory tool on the proximal end of the stem of one ofthe fixation arms.

16. Translate the accessory tool a short distance on the fixation armtoward the fixation site. By this action, center graft will be pushedinto pelvic cavity. Remove the accessory tool from the fixation arm.

17. Repeat steps 15-16 for the other fixation arm.

18. Repeat steps 15-17 until desired position of the center graft hasbeen achieved.

19. Trim mesh segment at least 1 cm proximal to the locking eyelet.Verify that discarded stems contain mesh on its distal end. If not, trimaway remaining stem from the mesh segment in vivo.

Various embodiments disclosed herein can be combined with neuromuscularstimulation to treat pelvic prolapse and any pain/discomfort associatedwith it or post-cancer or other reconstructive surgery.

The invention claimed is:
 1. A combination comprising a surgicalinsertion tool useful for implanting a pelvic implant, and a pelvicimplant, the tool comprising a handle, a shaft comprising a proximalshaft end attached to the handle, and a distal shaft end, a sheath thatengages the shaft and allows at least two configurations: a coveredconfiguration in which the sheath covers the distal shaft end, and anuncovered configuration in which the sheath covers a portion of theshaft and does not cover the distal shaft end, wherein the sheath movesrelative to the shaft, the implant comprising a support portion piece,an extension portion piece, and a tissue fastener at a distal end of theextension portion piece, the tissue fastener being capable of engagingthe distal shaft end, wherein: with the tissue fastener engaged with thedistal shaft end, the sheath covers the tissue fastener when the sheathis in the covered configuration and the sheath does not cover the tissuefastener when the sheath is in the uncovered configuration.
 2. Thecombination of claim 1 wherein the sheath is a hollow polymeric tubethat is separable from the shaft.
 3. The combination according to claim1 wherein the sheath is a hollow polymeric tube, with the tissuefastener engaged with the distal shaft end the sheath can slide over thedistal shaft end and the tissue fastener engaged with the distal shaftend to place the sheath in the covered configuration, the sheath engagesa mechanical stop when in the covered configuration, the mechanical stopcan be removed and the sheath can be placed in the uncoveredconfiguration.
 4. The combination according to claim 3 wherein themechanical stop comprises a moveable extension that can be moved toengage or disengage the sheath by an actuator located on the handle. 5.The combination according to claim 4 wherein the hollow tube sheathcomprises an aperture in a sidewall at the proximal tube end, in thecovered configuration, the extension is located within the aperture andinhibits movement of the hollow tube sheath in a proximal direction andin a distal direction along the shaft, the extension can be removed fromthe aperture to allow the hollow tube to be placed in the uncoveredconfiguration.
 6. The combination according to claim 3 wherein thehollow tube sheath comprises a proximal tube end and a distal tube end,the handle comprises a recess at a connection of the handle to the shaftproximal end, the recess being capable of accepting the proximal end ofthe hollow tube sheath, the hollow tube sheath moves from the coveredconfiguration to the uncovered configuration by the proximal tube endmoving in a direction toward the recess.
 7. The combination according toclaim 1 wherein, in the uncovered configuration, a length of from 0.5 to1.5 centimeters of the distal shaft end is uncovered.
 8. The combinationas recited in claim 1, wherein the sheath can be moved between thecovered configuration and the uncovered configuration, and in theuncovered configuration the sheath covers the proximal shaft end.
 9. Thecombination as recited in claim 1, wherein the implant comprises atissue support portion, and a set of two superior extension portionsextending from the tissue support portion, and a set of two inferiorextension portions extending from the tissue support portion, wherein,when the tissue support portion is placed to support tissue of a vagina,each superior extension portion can be connected to tissue of anopposing obturator foramen, and each inferior extension portion can beconnected to sacrospinous ligament.
 10. The combination as recited inclaim 1, comprising one or more of a grommet management tool and anadjusting tool.
 11. The combination as recited in claim 1, wherein thetool is adapted to engage the tissue fastener and to place the tissuefastener at a sacrospinous ligament, the combination further comprisinga second insertion tool adapted to place a second tissue fastener at anobturator foramen.
 12. The combination of claim 1 wherein the extensionportion piece comprises a mesh portion and a non-mesh portion.
 13. Thecombination of claim 12 wherein the extension portion piece comprises atissue fastener at an end of the mesh portion.
 14. The combination ofclaim 12 wherein the support portion piece comprises an adjustingengagement for adjustably engaging the extension portion piece.
 15. Thecombination of claim 14 wherein the support portion piece furthercomprises two additional tissue fasteners.
 16. The combination of claim1 wherein in the covered configuration the sheath is capable of coveringat least a portion of the extension portion piece.
 17. The combinationof claim 1 wherein in the covered configuration, the sheath covers atleast a portion of the extension portion piece.
 18. The combination ofclaim 1 wherein the tissue fastener comprises a base having a proximalbase end and a distal base end; an internal channel extending from theproximal base end at least partially along a length of the base towardthe distal base end; and a lateral extension extending from the base,and wherein the distal shaft end is capable of engaging the tissuefastener in a manner to allow the insertion tool to push the tissuefastener.
 19. The combination of claim 1 wherein the distal shaft end iscapable of engaging the tissue fastener in a manner to allow theinsertion tool to push the tissue fastener.
 20. The combination of claim1 wherein the extension portion piece comprises a mesh portion andnon-mesh portion, the mesh portion comprising a distal end connected tothe tissue fastener, and a proximal end connected to a distal end of thenon-mesh portion.
 21. The combination of claim 1 wherein in the coveredconfiguration, and with the tissue fastener engaged with the distalshaft end, the extension portion piece can be placed within the sheath.22. The combination of claim 1 wherein: the tissue fastener comprises abase having a proximal base end and a distal base end; an internalchannel extending from the proximal base end at least partially along alength of the base toward the distal base end; and a lateral extensionextending from the base; wherein the distal shaft end is capable ofengaging the tissue fastener in a manner to allow the insertion tool topush the tissue fastener; wherein the extension portion piece comprisesa mesh portion and non-mesh portion, the mesh portion comprising adistal end connected to the tissue fastener, and a proximal endconnected to a distal end of the non-mesh portion; and wherein in thecovered configuration and with the tissue fastener engaged with thedistal shaft end, at least a portion of the extension portion piece canbe placed within the sheath.
 23. A method of implanting an implant in apatient, the method comprising providing a combination as recited inclaim 1, engaging the tissue fastener with the distal shaft end, placingthe sheath over the shaft and engaged tissue fastener with the sheath ina covered configuration that covers the distal shaft end and engagedtissue fastener, inserting the shaft and engaged tissue fastener into apatient, with the sheath placed over the shaft in the coveredconfiguration, moving the sheath to an uncovered configuration thatuncovers the tissue fastener, and fastening the tissue fastener totissue.
 24. The method of claim 23 comprising inserting the tissuefastener into soft tissue selected from sacrospinous ligament andcoccygeus muscle.
 25. The method of claim 24 wherein the implantcomprises a tissue support portion, and a set of two superior extensionportions extending from the tissue support portion, and a set of twoinferior extension portions extending from the tissue support portion,the method comprising placing the tissue support portion to supporttissue of a vagina, fixing each superior extension portion to tissue ofan opposing obturator foramen, fixing each inferior extension portion tosoft tissue of sacrospinous ligament or coccygeus muscle.
 26. The methodof claim 23 wherein placing the sheath over the shaft and engaged tissuefastener, comprises placing the sheath over a portion of the extensionportion piece.